Prospective Randomised study Comparing Functional outcomes of Bulbospongiosus Muscle-Sparing Augmentation Urethroplasty with Dorsal and Ventral Approaches for Bulbar Urethral Strictures
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- To compare the post operative urine flow following dorsal onlay bulbospongiosus muscle-preserving augmentation urethroplasty with ventral onlay bulbospongiosus muscle-preserving augmentation urethroplasty for bulbar urethral strictures
研究概览
简要总结
All patients of age >21years and <60 years undergoing Primary Augmentation urethroplasty for Anterior urethral strictures involving only the proximal bulbar urethra measuring ≥ 2 cm and ≤ 5cm will be included in the study. Study participants will be randomised into 2 groups - Ventral onlay or Dorsal onlay. All patients will undergo the procedure under general anaesthesia in lithotomy position. Bulbospongiosus muscle will be preserved and buccal mucosal graft will be harvested in both groups. A ventral urethrotomy incision will be made and ventral augmentation of graft will be done for those in Ventral onlay group. A dorsal urethrotomy incision after one sided urethral mobilisation followed by dorsal augmentation of graft will be done for those in Dorsal onlay group. All patients will undergo catheter removal after 3 weeks and will be followed up once in 6 months in initial year and annually thereafter. During each visit, patients will be evaluated for outcomes in terms of PROM-USS questionnaire for surgery related outcome, IIEF-5 and MSHQ-EjD questionnaire for erectile and ejaculatory functions respectively. Data regarding the functional outcome measures will be analysed and compared between the two groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 21.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- Male
入选标准
- •Patients undergoing Primary Augmentation urethroplasty for Anterior urethral strictures involving only the proximal bulbar urethra measuring ≥ 2 cm and less ≤ 5cm.
排除标准
- •1.Traumatic bulbar urethral strictures.
- •2.Post-prostatectomy bulbar urethral strictures 3.Bulbar urethral strictures following periurethral abscess 4.Patients with a history of genitourinary tuberculosis, malignancy, or radiation affecting the bladder, prostate and urethra.
- •5.Redo-urethroplasty 6.Non availability of buccal mucosa or poor oral hygiene 7.Patients with psychiatric and neurological disorders.
结局指标
主要结局
To compare the post operative urine flow following dorsal onlay bulbospongiosus muscle-preserving augmentation urethroplasty with ventral onlay bulbospongiosus muscle-preserving augmentation urethroplasty for bulbar urethral strictures
时间窗: Once in 6 months in first year and annually thereafter for 2 years
次要结局
- To assess the erectile function, ejaculatory function and post void dribbling following dorsal onlay bulbospongiosus muscle-preserving augmentation urethroplasty with ventral onlay bulbospongiosus muscle-preserving augmentation urethroplasty for bulbar urethral strictures(Once in 6 months in first year and annually thereafter for 2 years)
研究者
Bhavatej Enganti
Asian Institute of Nephrology and Urology